Insertion head with a needle protection in its handle

ABSTRACT

An insertion head for medical or pharmaceutical applications includes a base having a lower side positionable on organic tissue; an insertion means movably mounted by the base and insertable into the tissue; where the insertion means is movable relative to the base from a protective position in which a free end of the insertion means is short of the lower side of the base, into an insertion position in which the free end protrudes beyond the lower side; and a receptacle that is open towards the lower side of the base and that can be detached from the base, and which accommodates at least the free end of the insertion means in its protective position.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/EP2006/005614, filed on Jun. 12, 2006, which claims priority toEuropean Patent Application No. 05 020 157.3, filed on Sep. 15, 2005,the contents of which are hereby incorporated in their entirety byreference therein.

BACKGROUND

The present invention relates to devices for the delivery,administration and passage of medicament and other fluids and methodsand uses thereof. The invention relates to an insertion head for medicalor pharmaceutical applications, which can be positioned on an organictissue, such as human skin, and which comprises an insertion means whichpenetrates into the tissue when the insertion head is positioned on thetissue or after the insertion head has been positioned on the tissue.The insertion head may be part of an infusion set for administering amedicine.

An insertion head is known from DE 198 21 723, comprising a base whichcomprises a lower side which can be positioned on organic tissue and viawhich a flexible cannula protrudes which may be immovably coupled to thebase and penetrates into the tissue when the base is positioned on thesurface of the tissue. For injecting into the tissue, the cannula isstabilized by an injection needle which protrudes through the cannula.In order to protect a user against injuries from the protrudinginjection needle and to protect the injection needle comprising theinsertion means against damage, a cylindrical needle protection isdetachably fastened to the lower side of the insertion head. The needleprotection requires space, and if carelessly handled, there is a dangerof it detaching from the insertion head. The user also requires bothhands in order to remove the needle protection, wherein after the needleprotection has been removed, one hand is still situated in the immediatevicinity of the then freely protruding injection needle.

German patent application No. 10 2004 039 408.3 discloses an insertionhead comprising an insertion means which can be moved from a protectiveposition in which it is accommodated in a receptacle, into an insertionposition in which it protrudes beyond the lower side of the insertionhead and, when the insertion head is placed on the surface of a tissue,penetrates into the tissue. The receptacle is an integral part of theinsertion head which comprises a hollow space which is open towards thelower side. In the protective position, the insertion means may beaccommodated in the hollow space such that its free end does notprotrude beyond the lower side or laterally. The insertion head does notrequire a separate protection for the insertion means and is thereforeas flat when delivered as it is when being used, i.e. when positioned onthe tissue, but is lengthened due to the integrally formed receptacle.

SUMMARY

It is an object of the invention to provide an insertion head which canbe safely handled, like for example the insertion head of DE 10 2004 039408, and is compact when being used, i.e. after it has been positionedon the surface of the tissue and the insertion means has penetrated in.

An insertion head such as the invention relates to comprises a baseincluding a lower side which can be positioned on organic tissue, aninsertion means which can be inserted into the tissue, and a receptaclewhich accommodates at least a free end of the insertion means when theinsertion means is in a protective position.

In accordance with the invention, when the insertion means is in theprotective position, at least its free end does not protrude beyond thelower side of the base. Rather, the insertion means is movably mountedby the base, such that it can be moved relative to the base from theprotective position into an insertion position in which its free endprotrudes beyond the lower side. In the protective position, theinsertion means may be short of the lower side of the base over itsentire length and may be completely or partly shielded and/or hiddenfrom view. In some embodiments, the insertion means in the protectiveposition points parallel or substantially parallel to the lower side orcontact area of the base. This favors a flat design for the base,wherein its height is measured at right angles to the lower side. Thereceptacle may also be detachably coupled to the base, and when coupled,the receptacle may provide protection for the insertion means, such thatthe base is relieved of this function, and the length on the base whichmay otherwise be required in order to fulfil the protecting function maytherefore be spared. The receptacle is open towards the lower side ofthe base. An opening for the insertion means may be sufficient, however,in certain implementations, the detachable receptacle surrounds the baseor a part of the base in the manner of a cup or dish, such as in theshape of a half-cup or half-dish. The receptacle may be removed upwardsfrom the base once a connection has been released.

To facilitate handling, the insertion head may be fitted with a handlethat projects from the base. The handle or at least a handle componentmay be detachably coupled to the base. Such a handle or handle componentmay be configured as a detachable receptacle for the insertion means. Inanother implementation, the handle comprises a handle part, whichprotrudes from the upper side of the base and from which the receptacleprojects laterally.

The handle may have a number of parts including a handle component whichcan be moved relative to the base and to an additional handle componentor a number of additional handle components. The movable handlecomponent may be coupled to the insertion means such that moving thishandle component moves the insertion means. An additional handlecomponent, which may form a counter bearing for moving the movablehandle component, may be unmoving relative to the base when coupled andmay form the detachable receptacle. In principle, the movable handlecomponent may instead form the detachable receptacle. Alternatively, anumber of handle components may also jointly form the receptacle.

In certain implementations, the handle may be fitted with a movablehandle component, and because of this, the insertion means may be movedby gripping and operating the handle. For example, the handle mayprovide the counter bearing for the movable handle component. Such acounter bearing is referred to as the additional handle component. Themovable handle component may, for example, be a push button. Theadditional handle component may be a casing from which such a pushbutton protrudes. In certain embodiments, the two handle componentsjointly form the handle, for example as halves of a two-part handle.

For automatically positioning by means of an inserter in accordance withthe invention, the insertion head, according to certain implementations,includes a holding structure, e.g., at its handle, which is in holdingengagement with a holding means of the inserter. If the handle includesa handle component immovably coupled to the base, and a handle componentwhich can be moved relative to the handle component, the unmoving handlecomponent may form the holding structure. The holding structure may bemoulded on the handle or on the unmoving handle component, for examplein one piece, and may be rigidly coupled to the handle or the unmovinghandle component.

In some embodiments, the movable handle component may be configured as areceiving member, but is referred to as the movable handle component inthe description of the embodiments of the insertion head below. However,in alternative embodiments, the receiving member may not be a handlecomponent but may serve to couple between an activating member and theinsertion means.

In further embodiments, the movable handle component may be movedparallel or substantially parallel to the lower side of the base. Thismay be a linear mobility. As an alternative to a translational mobility,the second component may be attached such that it can pivot.

The at least one additional handle component may be coupled to the baseimmovably. However, both handle components may be coupled to the basesuch that they can be moved relative to it.

For transmitting the movement of the movable handle component onto theinsertion means, a rigid coupling may be provided, i.e. the movablehandle component and the insertion means may be rigidly coupled ormoulded in one piece. If, for example, the insertion means can pivot,then a rigid coupling may result if the movable handle component canalso be pivoted. As compared to the insertion head of German patentapplication No. 10 2004 039 408.3, the insertion head in accordance withthe invention provides the additional handle component that may serve asa counter bearing for the user, and the force which has to be appliedfor the pivoting movement does not have to be absorbed by the tissue viathe base. Instead, this force may be absorbed by the user holding theadditional handle component. Alternatively, if an inserter is used inaccordance to the invention to position the insertion head on the tissueand insert the insertion means, the inserter absorbs the force.

In some embodiments, the movable handle component and the insertionmeans may be coupled via a transmission. In such a coupling, themobility of the handle component may not correspond to the mobility ofthe insertion means, but rather the two mobilities may respectively andindividually be configured as desired. Thus, the insertion means may bepivoted and the movable handle component may be moved translationallyand linearly guided. If the handle component is configured so that itmay be pivoted, its pivoting axis may be a different axis to that of theinsertion means. While the insertion means may be pivoted about arotational axis that may be parallel or substantially parallel to thelower side of the base, a pivotable handle component may be pivotedabout a rotational axis which is at right angles or substantially atright angles to the lower side. A transmission may, however, also havethe rotational axis of a pivotable handle component spaced away inparallel from the rotational axis of the pivotable insertion means. Inthis case, the pivoting angle of the handle component may be reduced orincreased by means of a transmission and transmitted onto the insertionmeans.

A transmission coupling may comprise a toothed wheel and a toothed rodin a toothed engagement such that the toothed wheel and toothed rod matewith each other when the handle component is moved. The toothed rod maybe coupled to the movable handle component such that a movement of thehandle component in the longitudinal direction of the toothed rod istransmitted into a rotational movement of the toothed wheel coupled tothe insertion means. Given an appropriately fine toothing and/or toothseparation, a comparatively short stroke of the movable handle componentmay be transmitted into a rotational movement of the toothed wheel, suchas a quarter-turn of the toothed wheel. The movable handle component maybe configured in one piece with the toothed rod. Instead of a couplingusing a toothed engagement via one or a number of pairs of teeth, thecoupling may also be configured as a guiding cam and engaging member ormay comprise such a guiding cam joint.

As previously discussed, the handle may be detachably coupled to thebase according to certain embodiments. Such a coupling may beautomatically released when the insertion means is moved into theinsertion position when the movable handle component is moved.Alternatively, however, handle or the base may include an additionalmovable component which, when operated, releases the coupling to thebase. The coupling between the handle and the base may be established bya frictional fit, but may also be based on a positive fit or acombination of a positive fit and a frictional fit. In order to createthe coupling, the base and the handle may be fitted with at least oneconnecting element, such that the base and the handle are in engagementwhen the connection is in place. In order to be able to release theconnection, at least one of the connecting elements may be moved out ofengagement, against a restoring elasticity force. In certainembodiments, the movable handle component may transfer the insertionmeans into the insertion position and release the connection by thesecond handle component moving one of the connecting elements out ofengagement against an elasticity force, e.g., by elastically bending theconnecting element via a sliding contact. Alternatively, the additionalhandle component may be configured as a single piece with the base ormay be non-detachably fastened to the base. In such an embodiment,however, the additional handle component may be shortened.

If the insertion head does not possess a handle or the detachablereceptacle is not part of such a handle, for example by being moulded onthe handle in one piece, hand movements required for detaching thereceptacle automatically may also move the insertion means from theprotective position into the insertion position. Thus, a push button orother operating element may, for example, be attached to the detachablereceptacle, or such an element can be suitably coupled to thereceptacle, and the receptacle can be detached from the base byoperating the operating element.

The insertion means may be a bend-resistant cannula or needle. In someembodiments, the insertion means is flexible, at least in the tissue.The insertion means may exhibit a bending resistance which is reducedwhen the insertion means is inserted, due to an interaction between thematerial of the insertion means and the surrounding tissue.Alternatively, the insertion means may also be configured to beflexible, for example as a flexible cannula, and stabilized by abend-resistant injection means while it is inserted into the tissue. Theinsertion means may be elongated in an insertion direction and may beslender.

If the insertion means is inherently flexible, it may be stabilized bymeans of an injection means in order to prevent the insertion means frombuckling when it is inserted into the tissue. The injection means may beconfigured as a thin injection needle. Once the insertion means has beeninserted into the tissue, the injection means may be removed. Such aninjection means may be removed by removing the detachable receptacle,for example using the handle. If the injection means is not yet coupledto the detachable receptacle in the protective position, it may becoupled automatically to the receptacle, or to a part coupled to thereceptacle, as it is moved into the insertion position. For thispurpose, a connecting element may be provided on its end facing awayfrom the free end of the insertion means, and the connecting element maypass into a connecting engagement with a connecting counter elementcoupled to the detachable receptacle, at the same time as the movementinto the insertion position is completed or shortly before. Theconnection or coupling may be a frictional fit, but may also comprise atleast a positive fit. The connecting element of the injection means maybe configured with a snapping connection with the connecting counterelement. Even a hinge with respect to the direction in which thedetachable receptacle is to be removed from the base may be sufficientfor a positive-fit connection, and accordingly, an elastic snappingengagement may not be required.

In the insertion position, the insertion means may protrude from thelower side of the casing. However, the insertion means may instead alsoprotrude from one side of the casing, providing it protrudes far enoughbeyond the lower side for penetrating into the tissue. In the insertionposition, the insertion means may protrude beyond the lower side of thecasing by a length which is adjusted to subcutaneous applications, forexample, directly away from or out of the lower side. For applicationswithin the skin or in intramuscular tissue, the insertion means may becorrespondingly shorter or longer. It will be understood that theinsertion means comprises the longitudinal portion which protrudes intothe tissue.

In some embodiments, the insertion means may be permanently and movablycoupled to the base. The insertion means may be permanently coupled tothe base means such that for the movement from the protective positioninto the insertion position and/or from the insertion position into theprotective position, it is not detached from the base. The insertionmeans may be permanently coupled to the base in which it cannot bedetached from the base at all, or at least not without a degree ofexertion of force or not without destroying it.

The insertion means may be coupled to the base such that the insertionmeans may be pivoted relative to the base. Optionally, the insertionmeans or at least its free end, once pivoted out, may be pivoted backinto the detachable receptacle. In such embodiments, the base and ajoint element coupled to the insertion means may provide a rotary joint.The insertion means may project from the joint element simply transverseto the rotational axis of the joint, for example by being moulded ontothe joint element, or it may also in principle be coupled to the jointin turn via a joint. In the position which the insertion means isassuming when its free end pivots beyond the lower side, thelongitudinal axis of the insertion means and the lower side enclose anacute angle of, for example, less than 50°. The angle may be smallerthan 30°, such that at the moment of pivoting out, the longitudinal axisor insertion means points may be substantially parallel to the lowerside or contact area of the base. The longitudinal axis of the insertionmeans, which is pivoted about the rotational axis, may intersect therotational axis. If the longitudinal axis of the insertion means doesnot intersect the rotational axis, but rather crosses it at a distance,the distance may be smaller than the length of the insertion means. Thedistance may be at most half as great as the penetration depth or lengthof the insertion means. In some embodiments, the pivoting angle of theinsertion means is 90°±10°. In other embodiments, however, the pivotingangle may also be smaller if the insertion means in the insertionposition does not point at rights angles to the lower side of the basebut rather at an acute angle, which however should be at least 30°.Correspondingly, the pivoting angle in such embodiments may be at leastabout 30° or any intermediate value between about 30° and about 90°. Thepivoting angle may also be greater than 90°.

In an alternative embodiment, the base may be arranged as a shiftingguide for the insertion means, on which the insertion means istranslationally guided as it moves from the protective position into theinsertion position and/or from the insertion position into theprotective position. In such an embodiment, the base and a joint elementwhich is coupled to the insertion means form a prismatic joint. Incertain implementations, the insertion means also simply projects fromsuch a joint element in the shifting direction. In another alternative,the insertion means or an injection means stabilizing it exhibits abending resistance, which enables the respectively free end of theinsertion means or an injection means stabilizing it to bend towards thelower side of the base, into the receptacle, such that the free endprotrudes into the receptacle and, in the receptacle, is detachablylatched to the base or otherwise detachably held in this bending stateagainst its restoring elasticity. Such an embodiment may be providedwhen the insertion means in the insertion position and the lower side ofthe base enclose an acute angle. In order to bend it in this way, theinsertion means may be fastened to the base or to the detachablereceptacle, slightly short of the lower side of the base, in order toobtain a certain bending line within a hollow space of the insertionhead. On the other hand, if the insertion means in the insertionposition protrudes directly or as closely as possible from the lowerside which contacts the surface of the tissue during use, i.e. isclamped fixedly or such that it can be axially moved and otherwisefixedly—on the lower side or at as short a distance from the lower sideas possible, such that a length of the insertion means or of aninjection means stabilising it, which can bend when penetrating into thetissue, is as short as possible. An insertion means which in theinsertion position projects directly from or close to the lower side maybe provided when the insertion means is not bent for the protectiveposition.

Although in some implementations it may be sufficient that the insertionmeans can be moved in one direction, i.e. once, relative to the base,for example from the protective position into the insertion position,the insertion means may also be moved back and forth between the twopositions, such that the insertion means can be moved into the insertionposition in order to be used, and back into the protective position inorder to be disposed of. For example, the coupling between the insertionmeans and the casing may comprise a positive fit which may form a joint.Alternatively, the connection may also be a non-positive fit or even amaterial fit, for example when the insertion means is bent in theprotective position.

The insertion head may be a part of an infusion set for administeringinsulin, an analgesic or some other medicine which can be administeredby infusion, or is provided for such a use. Instead of for administeringa medicine or any product which can be administered, the insertion headmay also serve diagnostic purposes. In such applications, the insertionmeans may serve as a support for a sensor for measuring for example theglucose concentration in a body fluid or some other physical and/orbiochemical parameter which is or can be relevant to a patient's stateof health. For diagnostic purposes, the insertion head may also beconfigured as a perfusion device. In such an embodiment, once theinsertion means has been inserted into the tissue, a rinsing fluid flowsthrough it which absorbs one or more constituents of the body fluid asit flows through the tissue, in order to analyze the rinsing fluidenriched with the one or more relevant constituents. Lastly, theinsertion head may form a combination of a device for administering aproduct and a diagnostic means. The insertion means may be appropriatelyconfigured for supplying a product, which may be a medicine or a rinsingfluid, or for draining a body fluid or just one or more constituents ofa body fluid. In such applications, the insertion means forms at leastone flow cross-section. The insertion means may serve to supply anddrain substances, also in combination. If the insertion head isconfigured as a measuring device, then the insertion means may alsoserve merely to position a sensor or a part of a sensor, i.e. as amechanical insertion means. In one development as a measuring device,the insertion head may, in addition to mechanically penetrating in, alsoserve to transmit control signals to the sensor and/or to transmitmeasurement signals from the sensor. Lastly, in combined applications,it may possess at least one flow cross-section for transportingsubstances, i.e. a flow conduit, and at least one signal conduit. Thesignal conduit may be omitted if the sensor is equipped for wirelesslyreceiving control signals and/or wirelessly transmitting measurementsignals. Lastly, the insertion means may also comprise two or moreinsertion elements which project separately. Thus, a first insertionelement may serve to transport substances into the tissue and another,second insertion element can serve to transport substances out of thetissue or merely to penetrate a sensor or a part of a sensor into thetissue. Using a number of insertion portions, which each comprise a flowportion, it may also be possible to administer different substancesusing the same insertion head. This may also be realized by an insertionmeans which forms a number of separate flow cross-sections in a commonportion.

In accordance with another embodiment, it may be possible to provide asecuring link in the receptacle of the insertion head in accordance withthe invention, which accommodates the insertion means together with theinjection needle or the latter alone in the protective position or inanother position such as for instance a locking position, where theinsertion means in conjunction with the injection needle, or theinjection needle alone can be inserted into the securing link, forexample in the protective position in the receptacle. Due to thespring-elastic quality of the injection needle, the tip of the injectionneedle may be elastically deformed and/or laterally deflected along thesecuring link into the protective position and/or into the receptacle,when it is pivoted back after use, in order to then latch into asecuring cavity behind a securing collar. In this position, theinjection needle may then be securely held in the protective position.An injury from the contaminated injection needle may no longer occur.

In accordance with another embodiment, the movable handle component maybe shifted far enough into the additional handle component that, oncethe process for transferring the insertion means from the protectiveposition into the insertion position has been completed, a control rampon the movable handle component moves against a deflecting ramp on aconnecting element which reversibly connects the base to the handle, inorder to deflect an engaging element out of its engagement position,such that the handle and the base can be separated. This embodiment, inconjunction with a second path of a link guide, may allow fortransferring the insertion head in accordance with the invention fromthe injection function to the supply function for supplying a medicine,without burdening the patient's tissue.

In accordance with another embodiment, the insertion means may beassociated with a holding structure which is moved with the insertionmeans, where the holding structure comprises a latching collar which,when the additional handle component is drawn out of the movable handlecomponent, enters into a latching engagement with an engaging element,in order to be able to prevent the injection means from pivoting outagain.

In accordance with certain embodiments, the receptacle is embodied inone piece with the handle or the additional handle component. In thiscase, the receptacle may be provided separately from the base.

The insertion means may also be associated with a holding structurewhich is moved with the insertion means, where the holding structurecomprises a securing structure. The latter should oppose a wall of themovable handle component which extends parallel to the movementdirection of the movable handle component. This may allow an engagingelement on the inner side of the wall to be in reversible engagementwith the securing structure when the insertion means is in itsprotective position. By means of these measures, it may be possible tohold the insertion means in conjunction with the injection needlesecurely in the protective position in the receptacle, in order to thenstill be able to pivot the insertion means in conjunction with theinjection needle as desired using the movable handle component, once aninitial resistance provided by the securing structure and the engagingelement has been overcome.

In accordance with another embodiment of the invention, an insertionhead may be provided with an insertion means which is held on the basevia a rotational or pivoting axis. A link block or trunnion may beprovided, which is arranged non-centrically in relation to therotational axis and in some implementations, separately from it, where alink guide is provided which co-operates with the link block. A movementof the movable handle component relative to the base over a first pathof a first portion of the link guide transfers the link block from afirst position which corresponds to the protective position of theinsertion means or needle, into a second position which corresponds tothe insertion position of the insertion means. This embodiment mayprovide a relatively complex guiding path for the insertion means as itis pivoted out of the receptacle, where at the same time, relativelyminor forces have to be exerted via the movable handle component, andjamming between the individual parts of the mechanism is highlyunlikely.

In accordance with another embodiment of the invention, a connectingelement may be provided which reversibly connects the base to thehandle, where in order to detach the handle from the base, the handlemay be moved over a second path perpendicular to the extending directionof the insertion means situated in the insertion position, where thelink guide comprises a second portion corresponding to the second path,such that when the handle is detached, the insertion means is not movedwith it, i.e. by suitably embodying the link guide, it is possible—afterthe injection needle and the insertion means have been injected into apatient's body—to move the handle parallel to the surface of the bodyand/or the surface of the flap, also referred to below as the plaster,without straining the organic tissue with parallel forces. In this way,it may be possible to separate the handle region from the base andtherefore the injection needle from the insertion means by operating thesame component, in this case the movable handle component, in order toperform both triggering and decoupling.

It is therefore possible in accordance with the invention to pivot thecontaminated injection means and/or injection needle back into themovable handle component again.

It may also be possible to perform the triggering and decoupling inimmediate succession, where the link block already passes the entirelink guide, which may alone pivot out the cannula or the insertion meansin conjunction with the injection needle, and simultaneously orimmediately after decouples the handle components, before the cannulacomprising the needle is applied. In this case, a breakable cohesion mayremain between the portion remaining in or on the patient's body and theportion of the insertion head, in accordance with the invention, whichmay be removed.

The insertion means may be associated with a securing structure, whichmay reversibly restrain the insertion means in the protective position.Thus, for example, the additional handle component may be embodied witha latching collar which may be brought into a reversible engagement witha complementary latching unit on the movable handle component. If aresistance is overcome, the additional handle component may be movedrelative to the movable handle component, and the cannula together withthe injection needle may be moved or pivoted into the applicationposition.

The insertion means may also be associated with a cannula casing whichis moved with the insertion means, where the cannula casing comprisesthe securing structure. The latter should oppose a wall of the movablehandle component which extends parallel to the movement direction of themovable handle component. This may allow an engaging element on theinner side of the wall to be in reversible engagement with the securingstructure when the insertion means is in its protective position. Bymeans of these measures, it may be possible to hold the insertion meansin conjunction with the injection needle securely in the protectiveposition in the receptacle, in order to then still be able to pivot theinsertion means in conjunction with the injection needle as desiredusing the movable handle component, once an initial resistance providedby the securing structure and the engaging element has been overcome.

In accordance with another embodiment, it may be possible to provide asecuring link in the additional handle component of the insertion headin accordance with the invention, which accommodates the insertion meanstogether with the injection needle or the latter alone in the protectiveposition, where the insertion means in conjunction with the injectionneedle, or the injection needle alone can be latched in the securinglink in the protective position in the receptacle. Due to thespring-elastic quality of the insertion means in conjunction with theinjection needle, the tip of the injection needle may be elasticallydeformed and/or laterally deflected along the securing link into theprotective position and/or into the receptacle when it is pivoted back,in order to then latch into a securing cavity behind a securing collar.In this position, the injection needle in conjunction with the insertionmeans may then be securely held in the protective position. The securinglink may also be provided in the receptacle or in the movable handlecomponent and/or in portions on different parts.

In accordance with another embodiment, the movable handle component maybe shifted far enough into the additional handle component that, oncethe process for transferring the insertion means from the protectiveposition into the insertion position has been completed, a control rampon the movable handle component moves against a deflecting ramp on aconnecting element, which reversibly couples the base to the handle, inorder to deflect a connecting means out of its engagement position, suchthat the handle and the base can be separated. This embodiment, inconjunction with the second path of the link guide, may allow fortransferring the insertion head in accordance with the invention fromthe injection function to the supply function for supplying a medicine,without burdening the patient's tissue.

The base may be coupled such that it can rotate or pivot to the cannulacasing, and the needle holder may be coupled such that it can rotate orpivot to the second or first handle components, where the two rotationaland/or pivoting mechanisms exhibit a common center and/or a common axis.

It may therefore be possible, in accordance with the invention, to pivotthe contaminated injection means and/or injection needle back into thesecond handle component again.

BRIEF DESCRIPTION OF DRAWINGS

Example embodiments of the invention are explained below on the basis offigures. Features disclosed by the example embodiments, eachindividually and in any combination of features, develop the subjects ofthe claims and also the embodiments described above. There is shown:

FIG. 1 is an insertion head of a first example embodiment, with theinsertion means situated in the protective position;

FIG. 2 is the insertion head with the insertion means situated in theinsertion position;

FIG. 3 is a handle of the insertion head of the first exampleembodiment;

FIG. 4 is a base of the insertion head of the first example embodiment,with the insertion means situated in the insertion position;

FIG. 5 is the handle of FIG. 3, in a view;

FIG. 6 is the base comprising the insertion means of FIG. 4, in a view;

FIG. 7 is an insertion head of a second example embodiment, with theinsertion means situated in the protective position;

FIG. 8 is the insertion head of the second example embodiment, with theinsertion means situated in the insertion position;

FIG. 9 is a handle of the insertion head of the second exampleembodiment;

FIG. 10 is a base of the insertion head of the second exampleembodiment, with the insertion means situated in the insertion position;

FIG. 11 is a system consisting of an insertion head and an inserter of afirst example embodiment, before it has been activated;

FIG. 12 is the system of the first example embodiment, after it has beenactivated;

FIG. 13 is a system consisting of an insertion head and an inserter of asecond example embodiment, before the insertion head has been activated;

FIG. 14 is the system of the second example embodiment, after it hasbeen activated;

FIG. 15 is the system of the second example embodiment, after theinsertion head has been positioned on the surface of a tissue;

FIG. 16 is an insertion head with the insertion means situated in theprotective position, in a lateral view;

FIG. 17 is the insertion head according to FIG. 16, with the insertionmeans situated in the insertion position;

FIG. 18 is the insertion head according to FIGS. 16 and 17, where thehandle together with the injection needle is separate from the basetogether with the insertion means;

FIG. 19 is the additional handle component and the movable handlecomponent, detached from the base, in a lateral view;

FIG. 20A is an insertion head with the insertion means situated in theprotective position, in a sectional view;

FIG. 20B is a detail from FIG. 20A, also in a sectional representation;

FIG. 21 is the insertion head in accordance with FIG. 20A, with theinsertion means situated in the insertion position, also in a sectionalrepresentation;

FIG. 22 is a sectional representation of the handle together with aninjection portion, separate from the base comprising the insertion meanswhich can be positioned on the patient;

FIG. 23A is a sectional representation of the additional handlecomponent and the movable handle component, after the movable handlecomponent has been drawn out of the additional handle component

FIG. 23B is an enlarged detail of area C from FIG. 23A

FIG. 23C is a section D-D in accordance with FIG. 23A, which is arrangedperpendicular to the section in accordance with FIG. 23A;

FIG. 24 is an insertion head in accordance with the invention, in aperspective view, before the application;

FIG. 25 is the insertion head in accordance with FIG. 24, after theapplication;

FIG. 26 is the insertion head in accordance with FIGS. 24 and 25, afterthe additional handle component and the movable handle componenttogether with the injection needle have been removed;

FIG. 27 is the additional handle component and the movable handlecomponent in a perspective view, after the movable handle component hasbeen drawn out of the additional handle component;

FIG. 28 is the base of the insertion head according to FIGS. 24 to 27,after a connector for supplying a medicine has been docked;

FIG. 29 is an insertion head with the insertion means together with theinjection needle situated in the protective position, shown without theadditional handle component;

FIG. 30 is the insertion head in accordance with FIG. 29, with theinsertion means together with the injection needle in the applicationposition;

FIG. 31 is an insertion head with the insertion means situated in theprotective position, in a lateral view; and

FIG. 32 is a section E-E through the insertion head in accordance withFIG. 31, in a top view.

DETAILED DESCRIPTION OF DRAWINGS

Similar or at least functionally similar parts are generally identifiedbelow using the same or comparable reference signs, such that in mostcases, it has been possible to omit repetition in the description. Theparts of the individual embodiments can mostly be exchanged, i.e.combined, with one another. The present invention is more fullydescribed in relation to the figures provided below.

FIG. 1 shows an insertion head of a first example embodiment, in alongitudinal section. The insertion head comprises a base comprising anaccommodating part or receptacle 1 and a flat part 2, which are mouldedfrom plastic in one piece. The lower side U of the base 1, 2 can bepositioned on organic tissue. The insertion head also comprises atwo-part handle comprising a first handle component 10 and a secondhandle component 12. The handle component 10 is immovably but detachablycoupled to the base. The handle component 12 is movably held on thehandle component 10 and the handle component 12 may be linearly shiftedboth relative to the handle component 10 and relative to the base 1, 2.The axis of mobility of the handle component 12 points parallel to alower side U of the base 1, 2. The direction of mobility is indicated onthe upper side of the handle component 12 by an arrow.

The base 1, 2 mounts an insertion means 5 such that it can pivot about arotational axis parallel to the lower side U. The insertion means 5 iselongated, and in the example embodiment, it is configured as a flexiblecannula. An injection means 15, which protrudes through the insertionmeans 5, is configured as a thin needle having a sufficient bendingresistance to inject the injection means 15, together with thesurrounding, conforming or nestling insertion means 5, through thesurface of the skin into subcutaneous tissue and so insert the insertionmeans 5. In certain embodiments, an adhesive pad is attached to thelower side U for fixing the insertion head on the tissue or surface ofthe skin.

A joint element 6 may be arranged as a shaft of a rotary joint, and withthe rotational axis as the joint axis, may provide a pivot for theinsertion means 5 and the injection means 15.

The base 1, 2 may be arranged as another joint element of the rotaryjoint in the form of a socket or also an open bearing eye. On therotational axis of the joint, an externally toothed wheel 8 is arrangedon each of the two sides of the joint element 6 and is non-rotationallycoupled to the joint element 6, for example is moulded in one piece. Oneof the two toothed wheels 8 can be seen in FIG. 1. The other ispositioned on the opposite side of the joint element 6 and is hidden bythe accommodating part 1 of the base 1, 2. The injection means 15protrudes through the joint element 6. A supply 7 for a medicinal fluid,for example insulin, is coupled to the joint element 6. The supply 7projects from the joint element 6, roughly at right angles to theinsertion means 5. The joint element 6, together with the supply 7, thetoothed wheels 8, the insertion means 5 and the injection means 15,forms a unit in relation to the rotational movement of the joint element6 and the toothed wheels 8 and the pivoting movement of the othercomponents mentioned.

The movable handle component 12 is provided with two toothed rods 18which are each in toothed engagement with one of the toothed wheels 8.Of the two toothed rods 18, only the one co-operating with the hiddentoothed wheel is depicted in FIG. 1. An identical toothed rod 18co-operates with the toothed wheel 8 depicted in FIG. 1. If the handlecomponent 12 is shifted in the direction indicated by the directionalarrow, during which movement the first handle component 10 guides thehandle component 12, the two toothed rods 18 mate with the two toothedwheels 8, such that the shifting movement of the handle component 12 istransmitted into a rotational movement of the joint element 6 and apivoting movement of the insertion means 5, the injection means 15 andthe supply 7.

The pivoting movement transfers the insertion means 5 from itsprotective position, shown in FIG. 1, into an insertion position. In theprotective position, the insertion means 5 and the injection means 15point parallel or substantially parallel to the lower side U of the base1, 2. The insertion means 5 and the portion of the injection means 15protruding in the same direction beyond the joint element 6 may beaccommodated in their common protective position in a hollow spaceenclosed by the accommodating part or receptacle 1, except for the lowerside U. Having the insertion means 5 situated in the protective positionmay reduce the chance of injury on the injection means 15. In addition,the insertion means 5 and the injection means 15 in the protectedposition may prevent damage due to careless handling. The receptacle 1may be arranged as a blind, such that the user cannot see the injectionmeans 15 from the upper side of the insertion head, nor from a lateralangle of view. An adhesive pad, which may be attached to the lower side,may be provided with a passage slit for the insertion means 5 and theinjection means 15.

The toothed rods 18 are respectively arranged on a lower side, facingthe lower side U, of two bend-resistant tongues which protrude in themovement direction from a lateral part of the handle component 12. Inaddition to the two tongues forming the toothed rods 18, at least oneother tongue protrudes in the movement direction from the lateral partof the handle component 12 and serves to linearly guide the movablehandle component 12 on a guide provided by the handle component 10.

In order to insert the insertion means 5 into the body tissue below theskin or into the skin, the user grips the handle of the insertion headbetween his thumb and forefinger. The handle components 10 and 12 areeach provided with a correspondingly shaped lateral indentation. Bypressing the handle components 10 and 12 together, the movable handlecomponent 12 is pressed up to and against a stopper provided by thefirst handle component 10. During this movement, the two toothed rods 18mate with the toothed wheels 8, such that the translational movement ofthe handle component 12 is transmitted into a rotational movement of thejoint element 6 and thus into a pivoting movement of the insertion means5 and the injection means 15. The path of the handle component 12, thediameter of the toothed wheels 8 and the fineness of the toothings maybe chosen such that a movement of the handle component 12 by a fewmillimetres, for example 4 or 5 mm, generates a pivoting movement of theinsertion means 5 and the injection means 15 by a pivoting angle of ator around 90° into an insertion position in which the insertion means 5and the injection means 15 protrude, at least roughly at right angles,beyond the lower side U of the base 1, 2.

FIG. 2 shows the insertion head with the insertion and injection means5, 15 situated in the insertion position.

At the end of the pivoting movement, the injection means 15 has beencoupled to the handle 10, 12, e.g., to the movable handle component 12.In the protective position (FIG. 1), there is no contact between theinjection means 15 and the handle 10, 12, such that the injection means15 can freely pivot together with the insertion means 5. In order toestablish the coupling, a connecting element 16 is arranged on, e.g.,fastened to, an end of the injection means 15, which is proximal in theinsertion position and by which the injection means 15 protrudes beyondthe joint element 6. The connecting element 16 comprises one or twoprotruding fins with which it grips behind a connecting counter elementof the handle component 12 in relation to the longitudinal direction ofthe injection means 15. The connecting counter element of the movablehandle component 12 may be configured as a collar area which may gripthe connecting element 16.

In order to position the insertion head on the surface of a tissue andinsert the insertion means 5 into the tissue, the user holds theinsertion head by its handle 10, 12 and moves it towards the surface ofthe tissue until the injection means 15 penetrates through the surfaceof the tissue, e.g., human skin, and penetrates into the skin. Theconforming or nestling insertion means 5 penetrates along with theinjection means 15, until the lower side U of the insertion head isplaced on the surface of the tissue and adhesively fixed on the surfaceof the skin, for example by means of an adhesive pad. In order toadminister the medicine, the injection means 15 is removed and thesupply 7 is coupled to a medicine reservoir, such as a medicine pump,via a connector which co-operates with the supply 7. In the presentlydescribed implementation, handle 10, 12 is detached from the base 1, 2before the supply 7 is coupled to the base. For example, once handlecomponents 10 and 12 have been pressed or shifted together, the handlecomponents 10, 12 may be detached from the base 1, 2. However, thecoupling may be automatically released when the handle component 12 ismoved, such that the handle 10, 12 can be drawn off in the proximaldirection, e.g., upwards in FIG. 2. During the linear drawing-offmovement, the injection means 15 slides through the insertion means 5and the joint element 6 resulting in the flow cross-section of theinsertion means 5 being exposed such that once the injection means 15has been drawn out, the flow cross-section is also simultaneouslyfluidly coupled to the supply 7. In this respect, the insertion head canbe embodied as described for example in DE 198 21 723 C1 and DE 10 2004039 408.3, which are herein incorporated by reference in theirentireties, for any purpose.

FIGS. 3 and 4 show the two parts of the insertion head detached fromeach other, i.e. the base 1, 2 comprising the insertion means 5 on theone hand, and the handle 10, 12 comprising the injection means 15 on theother hand, in a mutually aligned position in which the longitudinalaxis of the insertion means 5 and the longitudinal axis of the injectionmeans 15 are flush with each other. In FIG. 3, a cavity 3 in the base 1,2 is depicted in which the parts are coupled and the handle component 12is moved, and one of the two toothed rods 18 retracts into the cavity 3and mates with the toothed wheel 8 arranged in the cavity 3. The cavity3 is slit-shaped. A connecting element 19 of the handle 10, 12 isdepicted, which when coupled, engages in a positive fit with aconnecting counter element of the base 1, 2 and holds the handle 10, 12on the base 1, 2 and, in combination with contact areas of the handle10, 12 and the base 1, 2, fixes it relative to the base 1, 2. Theconnecting element 19 protrudes like a stub from an elastic flap 13projecting from the handle component 10 in the distal region, in adirection pointing parallel to the lower side U of the base 1, 2 and,when coupled, into a receptacle of the base 1, 2, for example a holeshaped congruently with the connecting element 19, such that a movementof the handle 10, 12 in the longitudinal direction of the injectionportion 15 is prevented when the connection exists. In order to releasethis coupling, another tongue (not shown) which protrudes from thelateral part of the movable handle component 12 moves between the base1, 2 and the flap 13 bearing the connecting element 19 when the handlecomponent 12 is moved, and bends the flap 13 slightly away from the base1, 2, but enough to release the positive-fit connection between theconnecting element 19 and the connecting counter element, such that thehandle 10, 12 comprising the injection means 15 can be drawn off in itslongitudinal direction from the base 1, 2.

FIGS. 5 and 6 again show the parts of the insertion head detached fromeach other, in a view onto the rear side facing away in FIGS. 1 to 4. Inthis view, the connecting counter element 9 of the base 1, 2 depicted inFIG. 6, which when coupled, i.e. in engagement with the connectingelement 19, holds the handle 10, 12 on the base 1, 2.

The base 1, 2 shown individually in FIGS. 4 and 6, which is the supportfor the insertion means 5 and for the parts 6, 7 and 8 which togetherwith it are configured as a pivoting unit, remains on the surface of thetissue and is in this sense a retained part. By contrast, the handle 10,12, which then serves as a support for the injection means 15, isdisposed of or detached from the injection means 15 again and suppliedto another application, while the injection means 15 is disposed of. Theretained part 1-9 may be flat and worn under the clothes. The insertionmeans 5 may be flexible yet stable such that the insertion means iscomfortably insertable but stable so that medicine may be reliablysupplied.

The handle 10, 12 may also be used in embodiments of the insertion headin which the insertion means is not inherently flexible like theinsertion means 5, but is rather bend-resistant enough for injectingwithout being externally stabilized. In such embodiments, the additionalinjection means 15 may be omitted. In such embodiments, the handle 10,12 hands the insertion head and does not support a stabilising injectionmeans 15. An insertion means 5 modified in this way may be configured asan injection cannula having a hollow cross-section or as an injectionneedle having a solid cross-section and one or more flow channels at itsouter circumference, which becomes more flexible after it has beeninserted, due to interaction with the tissue.

FIGS. 7 to 10 show a second example embodiment of an insertion head.Aside from the differences described below, the insertion head of thesecond example embodiment corresponds to the insertion head of the firstexample embodiment.

Thus, by way of example, an adhesive pad which is fastened to the lowerside U is shown, such as could also be attached to the insertion head ofthe first example embodiment.

The receptacle 1 and the first handle component 11 have been modified ascompared to the first example embodiment. Unlike the first exampleembodiment, the insertion means 5 and the injection means 15 areaccommodated in the receptacle 1, which is provided by the accommodatingpart, over a short portion. In the second example embodiment, the handlecomponent 11 comprises a receptacle 14 for the insertion means 5 and theinjection means 15. The receptacle 1 is laterally provided with a cavity4, in the form of a slit, which is open towards the lower side U andthrough which the insertion means 5 and the injection means 15 protrudeout of the receptacle 1 in the protective position. The receptacle 1 isin turn accommodated in the receptacle 14. The receptacle 14 is opentowards the lower side U, but otherwise encloses the insertion means 5and the injection means 15, for example using an opaque material.

In order to pivot the insertion means 5 and the injection means 15 fromthe protective position into the insertion position, the user performsthe hand movements described in relation to the first exampleembodiment, i.e. the movable handle component 12 is pressed against themodified handle component 11. When there is a mating toothed engagement,the insertion means 5 and the injection means 15 in the cavity 4 pivotout of the receptacle 1 and receptacle 14, into the insertion position.

FIG. 8 shows the insertion head of the second example embodiment, withthe insertion means 5 and the injection means 15 situated in theinsertion position.

FIGS. 9 and 10 correspond to FIGS. 3 and 4 of the first exampleembodiment. However, as depicted in FIG. 10, the base 1, 2 may beshortened as compared to the base 1, 2 of the first example embodiment,because base 1, 2 does not protect the insertion and injection means 5,15, but rather the handle 11, 12 serves a protecting function for theinsertion means 5 and the injection means 15 in their protectiveposition.

FIG. 11 shows a system of a first example embodiment, consisting of theinsertion head of the first example embodiment and an inserter, whichserves to position the insertion head on the tissue, such that the userdoes not have to grip the insertion head between his fingers whenpositioning it. For example, the user does not hold the insertion headby its handle when the insertion means 5 is transferred into theinsertion position. This activation of the insertion head is performedwith the aid of the inserter. The user may therefore be securelyprotected against pricking injuries, and the insertion means 5 and theinjection means 15 may be securely protected against damage due tocareless handling, i.e. by the inserter.

The inserter comprises an inserter casing 20 configured as a sleeve partcomprising a base and may exhibit the shape of a cup when viewed fromthe outside. The inserter casing 20 accommodates a holding means and adrive for the insertion head. The holding means comprises a holdingspring, for example a leaf spring, which holds the insertion head in theinitial position shown in FIG. 11 relative to the inserter casing 20. Ina holding engagement, the holding spring grips behind a holdingstructure 17, which is arranged on the handle 10, 12 depicted in FIGS.1, 2, 3 and 5. The holding engagement may be released, against therestoring elasticity force of the holding spring.

The drive comprises an advancing element 22, which may be arranged inthe inserter casing 20 such that it is linearly movable in and counterto an advancing direction V. The advancing direction V coincides with acentral longitudinal axis of the inserter casing 20. The drive alsocomprises a force generator 23 which acts on the advancing element 22 inthe advancing direction V. The force generator 23 comprises two pairs oflegs 24 which may be coupled via a joint, and the two pairs of legs 24may be arranged symmetrically with respect to the central longitudinalaxis of the inserter casing 20, i.e. symmetrically with respect to theadvancing direction V. Each of the pairs of legs is suspended in arotary joint 25 which is fixed relative to the inserter casing 20. Thetwo legs 24 of each pair of legs may be rotatably coupled in a freerotary joint 26. The leg 24 facing away from the fixed joint 25 may alsobe coupled to the advancing element 22 in a rotary joint 27. One or moresprings (not shown) may tense the leg-joint-advancing elementarrangement in the advancing direction V. The arrangement of legs 24 andjoints 25, 26 and 27 guides the advancing element 22. Additionally oralternatively, the inner surface area of the inserter casing 20 mayguide the advancing element 22. A blocking member 29 may also beprovided which is in blocking engagement with the inserter casing 20.The blocking engagement may prevent an advancing movement of theadvancing element 22. The blocking member 29 may be arranged as theblocking engagement with the cladding structure provided by the insertercasing 20, or equally with another structure which is fixedly coupled toit in relation to the advancing direction V. The blocking engagement maybe released by operating a push-button trigger 28.

The inserter also includes an activating member 21 coupled to theinserter casing 20 such that it can move in and counter to the advancingdirection V. The activating member 21 may be arranged as a bushing inrelation to the inserter casing 20, such that a two-part telescopinginserter casing comprising casing parts 20 and 21 is obtained. For thesake of distinguishing it with regard to its function, however, thecasing part 21 shall continue to be referred to as the activatingmember. The activating member 21 forms the lower side U₂₁ of theinserter, via which the inserter may be placed on the surface of thetissue in order to position the insertion head. In the initial positionof the insertion head in FIG. 11, the lower side U₂₁ of the inserter andthe lower side U of the held insertion head each point in the advancingdirection V, which may form a surface, e.g., substantially normalsurface, for the two lower sides.

The activating member 21 comprises an outer sleeve part and an innersleeve part which may be coupled on the lower side U₂₁ and leave anannular gap. The inserter casing 20 protrudes into the annular gap andguides the activating member 21 in a sliding movement.

In the state shown in FIG. 11, the activating member 21 assumes aretracted position relative to the inserter casing 20, and the inserterexhibits its shortest length as measured in the advancing direction V.In this state of the inserter, the insertion head is inserted, i.e.brought into holding engagement with the holding means of the inserter.Instead of inserting the insertion head, the inserter may also be placedover the insertion head lying on a support. The position and geometry ofthe holding means may be chosen such that the holding engagement isautomatically established when the inserter is placed on the insertionhead. Immediately after the insertion head has been accommodated, forexample by being inserted, the insertion means 5 of the insertion headis situated in its protective position. In this sense, the insertionhead may be inactive. The inserter includes means, i.e. the activatingmember 21, which when operated can move the insertion means into theinsertion position and so activate the insertion head.

In order to activate the insertion head, the activating member 21 andthe insertion head together form a joint, e.g., a cam joint. The twojoint elements of the joint are a guiding cam 21 a, which forms theactivating member 21, and an engaging element 12 a provided by themovable handle component 12. In the coupling via which the activatingmember 21 acts on the insertion means 5, the movable handle component 12may provide an input and/or receiving member of the insertion head. Ifthe activating member 21 is moved in the advancing direction V relativeto the inserter casing 20, the guiding cam 21 a slides over the engagingelement 12 a, i.e. over the contact area of the receiving member such asthe movable handle component 12, which forms the engaging element 12 a.Due to the pressing contact and the profile of the guiding cam 21 awhich is inclined with respect to the advancing direction V, the handlecomponent 12 is moved transverse to the advancing direction V, towardsthe additional handle component 10, and the insertion means 5 pivotsinto the insertion position, as described for the insertion head itself.The movable handle component 12 forms the engaging element 12 a at itsupper end facing away from the base 1, 2, e.g., with its outer edge. Theguiding cam 21 a faces the lower side U₂₁ of the inserter. Theinclination is chosen such that the guiding cam 21 a is inclined, froman end facing away from the lower side U₂₁, in the advancing direction Vaway from the insertion head and/or the insertion means 5 which ispivoted out when activated or from the central longitudinal axis of theinserter. The angle of inclination may be constant throughout such thatthe guiding cam 21 a is a slant, i.e. an oblique line or area.

For practical handling, it may be suitable for the user to hold theinserter by the activating member 21 with one hand after the insertionhead has been accommodated, for example by gripping around theactivating member 21, and to draw the inserter casing 20 counter to theadvancing direction V relative to the held activating member 21 with theother hand. This is also understood to mean operating the activatingmember. The advancing element 22 and the force generator 23 may be movedtogether with the inserter casing 20 relative to the activating member21. The insertion head held in the initial position may be slaved by theholding means, i.e. it may be moved relative to the activating member21, counter to the advancing direction V. The engaging element 12 aslides along the guiding cam 21 a. Via this interface which is based ona pressing contact, the movable handle component 12 is moved transverseto the advancing direction V, and the insertion means 5 pivots into theinsertion position. The insertion head may be activated at the end ofthe extending movement which the inserter casing 20 and the activatingmember 21 perform relative to each other.

FIG. 12 shows the system consisting of the inserter and the insertionhead in its activated state. The inserter casing 20 and the activatingmember 21 assume their extended position relative to each other. In theextended state, the walls of the inserter casing 20 and the activatingmember 21 surround the activated insertion head up to and beyond thefree end of the insertion means 5 and the injection means 15, i.e. thetip of the injection means 15 is slightly short of the lower side U₂₁ ofthe inserter.

In the extended position, the inserter casing 20 and the activatingmember 21 are blocked relative to each other. Relative movements in orcounter to the advancing direction V are not possible in the blockedstate. Upon reaching the extended position, the inserter casing 20 andthe activating member 21 may be automatically blocked on each other.

In order to position the insertion head, a user may place the inserteron the surface of the skin. When the inserter has been placed, the userpresses the trigger 28. The trigger 28 acts on the blocking member 29via a cam joint, for example, via a pair of slants. Due to the action ofthe trigger 28, the blocking member 29 may be moved out of its blockingengagement with the inserter casing 20, such that the advancing element22 can be moved in the advancing direction V due to the action of theforce generator 23. The force generator 23 may abruptly accelerate theadvancing element 22, and the advancing element 22 may act on theinsertion head like a hammer. In the first portion of the advancingmovement, the holding spring springs out of its holding engagement withthe holding structure 17 of the insertion head, i.e. the holdingengagement is released. The acceleration of the advancing element 22 inthe advancing direction V may be large enough for the pressing contactbetween the advancing element 22 and the insertion head to be securelymaintained, at least until the lower side U of the insertion head is atthe same height as the lower side U₂₁ of the inserter and is thuspositioned on the surface of the tissue. According to certainimplementations, the injection means 15 and insertion means 5 may havepenetrated through the surface of the skin and into the tissue.

After the insertion head has been positioned on the surface of the skin,the user grips the handle 10, 12 and draws it off from the base 1, 2,where the injection means 15 may be automatically drawn out of theinsertion means 5 and off from the base 1, 2.

In order for the injection means 15 to also be drawn out automatically,the holding engagement between the holding means of the inserter and theholding structure 17 of the insertion head may be maintained by amodification to the inserter and may not be released by the accelerationof the advancing element 22, as in the example embodiment described. Insuch a modification, the holding means may be coupled fixedly to theadvancing element 22, such that it is slaved in its discharge movementin the advancing direction V. In order to release the holdingengagement, the inserter may be fitted with a deflector which, after theinserter has been removed from the tissue and when the inserter casing20 and the activating member 21 are shifted together, automaticallyreleases the insertion head from the holding engagement. Alternatively,such a deflector may also be provided independently of the activatingmember 21, and may be separately operated in order to release theholding engagement.

FIGS. 13-15 show a system of a second example embodiment, consisting ofan insertion head and an inserter. The insertion head may be any of theinsertion heads provided in the example embodiments, or combinations orvariants thereof. According to the embodiment of FIGS. 13-15, theinserter is modified. The components of the inserter of the secondexample embodiment which in relation to their function are comparable tothe components of the inserter of the first example embodiment arerespectively marked with the reference signs of the first exampleembodiment, raised by the number 10. Thus, the statements made withrespect to the first example embodiment may apply to the inserter casing30 and the activating member 31, as far as their shape and connectionand also their relative mobility are concerned. The same also applies inrelation to advancing element 32, the holding means and the forcegenerator 33, and also the trigger 38 and the blocking member 39. Whereno reference is made in the following to differences, and nothingcontrary is shown by the figures, the statements made with respect tothe first example embodiment likewise also apply to the second exampleembodiment.

The inserter of the second example embodiment differs from the inserterof the first example embodiment with regard to the joint via which theactivating member 31 acts on the insertion head, in order to activate itthrough the drawing-up movement of the inserter casing 30 relative tothe activating member 31. In the second example embodiment, the inserteritself provides the joint, i.e. comprising two joint elements 31 a and41 a, one of which forms the activating member 31 and the other of whichforms an effector member 41. The effector member 41 may be mounted bythe inserter casing 30 such that it is movable back and forth transverseto the advancing direction V, e.g., at right angles to the advancingdirection V. The joint 31 a, 41 a may be a cam joint. The guiding cam 31a may correspond to the guiding cam 21 a of the first exampleembodiment. The effector member 41 provides the engaging element 41 awhich slides along the guiding cam 31 a when the inserter is lengthenedand, due to the inclined profile of the guiding cam 31 a, generates atransverse movement of the effector member 41 towards the centrallongitudinal axis of the inserter when the inserter is drawn up. Themovement pointing counter to the advancing direction V, which theinserter casing 30 performs relative to the activating member 31 when itis drawn up, is thus converted in the joint 31 a, 41 a into thetransverse movement of the effector member 41. Its joint element orengaging element 41 a may be configured like a guiding cam, but in termsof transmission may be referred to here as the engaging element. Theengaging element 41 a may alternatively, for example, also be shaped asa cam or burl. The engaging element 41 a may equally be referred to as aguiding cam, and in another modification, the joint element 31 a may beconfigured as a protruding cam or burl.

The interface via which the inserter activates the insertion head may beconfigured as a pressing contact and exists between the effector member41 and the receiving member or movable handle component 12 of theinsertion head. This pressing contact, e.g., loosely pressing contact,may simplify handling because a joint connection may not need to beestablished in order to the activate the insertion head. For example, itmay be sufficient to accommodate the insertion head in combination withoperating the activating member 31, which, in the example embodimentsmay be performed by the drawing-up movement. The pressing contact, i.e.the pressing force exerted by the effector member 41, acts on themovable handle component 12 parallel to the direction of its mobilityrelative to the base 1, 2. By interposing the effector member 41 andmoving the joint 31 a, 41 a completely to the inserter, there may be inthe second example embodiment no force exerted on the handle component12 transverse to the direction of mobility of the handle component 12.

FIG. 14 shows the system with the insertion head activated. In thecourse of the drawing-up movement of the inserter casing 30, which isalso understood to mean operating the activating member 31, theinsertion means 5 and the injection means 15 have been pivoted into theinsertion position, such that their common longitudinal axis points inthe advancing direction V. The movable handle component 12 has releasedthe coupling between the handle 10, 12 and the base 1, 2, as describedfor the insertion head. However, the frictional fit between theinsertion means 5 and the injection means 15 holds the base 1, 2 on thehandle 10, 12 in the holding engagement, as in the first exampleembodiment.

The blocking engagement, in which the blocking member 39 is stillsituated with the inserter casing 30 or a structure fixedly coupled tothe inserter casing 30, may be released by operating the trigger 38, andthe force generator 33 accelerates the advancing element 32 in theadvancing direction V. The acceleration may be abrupt, such that thedrive means 32, 33 of the second example embodiment also acts like ahammer. The drive force may be generated by two leg springs, each one ofwhich acts on one of the two pairs of legs. The legs 24 which arefastened via the rotary joints 35 (fixed), 36 and 37 and are coupled viaa toothed engagement which may provide a synchronous extending movementof the two pairs of legs.

In order to prepare the inserter for another application, after theinsertion head has been positioned, the effector member 41 id moved fromthe position shown in FIG. 14 back again into the position shown in FIG.13. For this return movement, the activating member 31 and the effectormember 41 form an additional joint 31 b, 41 b, which in the exampleembodiment is a cam joint. The activating member 31 forms the guidingcam 31 b for the additional joint, and the effector member 41 forms theengaging element 41 b. The guiding cam 31 b may run parallel orsubstantially parallel to the guiding cam 31 a. The guiding cams 31 aand 31 b may be provided on the inner sleeve part of the activatingmember 31 such that the guiding cam 31 a is arranged at the inner areaand the guiding cam 31 b is arranged at the outer area of the innersleeve part. The guiding cams 31 a, 31 b may oppose each other atroughly the same height in terms of the advancing direction V. Theengaging element 41 b may also oppose the engaging element 41 a at adistance, such that the inner sleeve part of the activating member 31may retract and extend between the two engaging elements 41 a and 41 b.

FIG. 15 shows the system of the second example embodiment with theinsertion head positioned. The inserter is removed from the insertionhead. The user may then draw the handle 10, 12 off from the base 1, 2and couples the insertion head to a catheter of an infusion pump.Alternatively, the holding means may be coupled fixedly to the advancingelement 32 and may hold the handle 10, 12, and the inserter with thehandle 10, 12 may be removed from the base. The holding engagement maybe released, for example by means of an additional deflector, and thehandle 10, 12 may disposed of, with the injection means 10 or on itsown.

In order to prepare the inserter for use with another insertion head,the user shifts the inserter casing 30 and the activating member 31 backtogether into the retracted position, as shown in FIG. 13 with theinsertion head retracted. During the retracting movement, the innersleeve part of the activating member 31 moves between the engagingelements 41 a and 41 b of the effector member 41. During this retractingmovement, the additional joint coupling between the guiding cam 31 b andthe engaging element 41 b may be established. During the retractingmovement, the effector member 41 may thus be moved in the joint 31 b, 41b, into the end position assumed in FIG. 13, i.e. is moved transversely,e.g., radially, outwards in relation to the central longitudinal axis ofthe inserter.

The advancing element 32, which is extended due to the action of thespring means 33 in the advancing direction V, opposes an end-facing sideof the inner sleeve part facing away from the lower side U₃₁ of theactivating member 31. The advancing movement of the advancing element 32may be stopped by an abutting contact against this end-facing side. Theactivating member 31 is geometrically dimensioned such that when thetelescope 30, 31 is in the extended position, the activating member 31stops the advancing element 32 exactly when the lower side U of theinsertion head has reached the height of the lower side U₃₁ andtherefore just contacts the surface of the skin when the inserter isplaced on the skin. During the retracting movement of the insertercasing 30 relative to the activating member 31 or of the activatingmember 31 relative to the inserter casing 30, the advancing element 32may be pressed deeper into the inserter casing 30, against the force ofthe force generator 33, due to the abutting contact by the activatingmember 31, until the blocking member 39 is in blocking engagement again,as shown by way of example in FIGS. 13 and 14.

FIG. 16 shows another embodiment of the insertion head in accordancewith the invention. The insertion head comprises a movable handlecomponent 12 which may be shifted into an additional handle component10. Shifting the movable handle component 12 into the additional handlecomponent 10 pivots a cannula casing 17 b about a joint 6, where thecannula casing 17 b still bears the insertion means 5 and the injectionmeans 15 in the protective position. While the movable handle component12 is operated, the link block 44 in the link guide 42 may be moveddownwards towards the joint element 6, which causes a rotational orpivoting movement for the holding structure 17 and therefore for theinsertion means and the insertion needle. As soon as the link block ortrunnion 44, e.g., with a cylindrical projection on one or both sides,has entered the cam region of the link guide 42, the pivoting movementfrom the protective position into the insertion position has beencompleted. The additional handle component 10 is also fitted with aconnecting means 16 b which is in engagement with a correspondingportion 49 on the base 1, so as to reversibly connect the base to thehandle 10, 12.

The link block 44 can of course also exhibit a different position.

Thus, the link block 44 may also be arranged further down and thentravel upwards when the parts 17 a, 17 b are pivoted. Differentconfigurations for the link guide and the link block are possible here.

In FIG. 17, the movable handle component 12 is sunk into the additionalhandle component 10, where the insertion movement of the movable handlecomponent 12 into the additional handle component 10 has caused theinsertion means 5, together with the injection means 15, to be pivotedout of the receptacle 14 (see FIG. 19) into the insertion position. Thisembodiment in accordance with FIGS. 16-19 therefore provides a couplingbetween the handle components and the pivotable insertion means which isan alternative coupling to the embodiments discussed above.

FIG. 18 shows how the handle, consisting of the handle components 12 and10, can be decoupled from the base 1. The base 1 contains a cavity 49with which a connecting means 16 b on the handle 10, 12 was inengagement (see FIGS. 16 and 17), whereas in the representation inaccordance with FIG. 18, this engagement has been broken, such that thehandle 10, 12 can be drawn off from the base 1.

FIG. 19 shows the handle 10, 12 in accordance with FIG. 18, where themovable handle component 12 is drawn out of the additional handlecomponent 10, such that the link block or trunnion 44 in the link guide42 has been guided upwards, whereby the cannula casing 17 b and theneedle holder 17 a with the injection means 15 fixed to it have againbeen pivoted into the original protective position in the receptacle 14or a locking position close to it. The connecting means 16 b, which ispositioned at the end of a spring stay 16 a, then has no function, sinceit no longer has to hold a connection to the base 1.

FIG. 20A shows the insertion head in accordance with another embodimentin accordance with the invention, in a situation before an applicationand/or during storage. The insertion means 5 with the injection means 15partially accommodated in it is situated in the protective position inthe receptacle 14. On the flap 13 or plaster 13, a protective film isapplied to the lower side, in order to actively hold the adhesion pointsof the plaster 13. In accordance with FIG. 20A, a septum 58 is alsoprovided such that the injection means 15 may be inserted and removed.In addition, septum 28 provides a seal for the insertion means 5. Theconnection portion coupled perpendicularly to the injection means 15 maycorrespondingly also be provided with a septum 56 which is intended toenable a sealed connection to a supply conduit or connector (see FIG.28).

On a needle holder 17 a which is arranged on the cannula casing 17 b andholds the injection means 15, a securing structure 46 is provided on theside facing away from the base 1, as shown by the image detail inaccordance with FIG. 20B. In the state shown, an engaging element 48 isin engagement with the securing structure 46 and provides a resistancewhich acts against the movable handle component 12 being inserted intothe additional handle component 10 by accident. The operator of theinsertion head in accordance with the invention in accordance with thisembodiment has to initially apply an increased force, in order toovercome the engagement between the engaging element 48 and the securingstructure 46, so as to perform the pivoting process for the insertionmeans 5 together with the injection means 15 from the protectiveposition in the receptacle 14 as shown in FIG. 20A, into the applicationposition as shown in FIG. 21.

It is also possible to realize the securing structure 46 using latchingmeans corresponding to the elements 52, 54, which can for example beprovided on the additional handle component 10 and the movable handlecomponent 12 and unlatched by shifting one into the other.

The insertion means 5 together with the injection means 15, which areinjected into a patient's tissue in FIG. 21, are disassembled inaccordance with FIG. 22, i.e. the injection means or injection needle 15is drawn out of the insertion means 5. The septum 58 is closed, and theinsertion means 5 is ready to insert a medicine into a patient's body.

FIG. 23A shows how the movable handle component 12 has been drawn backout of the additional handle component 10, such that the cannula casing17 b has been pivoted back again into its position associated with theprotective position. The injection means 15 can be moved via theoriginal protective position into a position above the protectiveposition, i.e. above a latching collar 60 which is explained below. Inthis position, the injection means 15 is secured, as can be seen in theenlarged image 23B, by a latching collar 60 at the end of the needleholder 17 a passing into engagement with the engaging element 48. Inthis position, it is then no longer possible to deflect the contaminatedinjection means 15 out of the handle 10, 12 again, because a lockingeffect is provided by the engaging element 48 in conjunction with thelatching collar 60. The injection means 15 is held behind the latchingcollar in a locking position. FIG. 23C reproduces a section D-D inaccordance with FIG. 23A and depicts a securing link 50 which serves totransfer the used or contaminated injection means 15 into a secured linkportion behind a securing collar 50 a. An unused, sterile injectionmeans can conversely be held in a different position in front of thesecuring collar 50 a before it is used.

The sectional representation in accordance with FIG. 23C also showsguides 62 which enable the movable handle component 12 to be guidedwithin the additional handle component 10. If the injection means 15 ispivoted back into an inactive position in the receptacle, it is moved,e.g., by flexibly deforming, through the securing link 50, in order tothen be positioned in the upper region of the securing link 50 behindthe securing collar 50 a in order to then securely remain in a blockedposition.

FIGS. 24 to 28 show different stages of the application of an insertionhead in accordance with the invention. FIG. 24 shows the movable handlecomponent 12 in a position protruding from the additional handlecomponent 10, in which the insertion means 5 together with the injectionneedle 15 are in their protective position. In the representation inaccordance with FIG. 25, the movable handle component 12 has been movedinto the additional handle component 10, such that, as is shown by FIG.26, the insertion means together with the injection means can beinjected into a patient's body. FIG. 26 then shows the state accordingto which the insertion means together with the injection means 15 hasbeen injected into a patient's body, where the injection means 15 thenhas no further function and can be drawn out of the insertion means,i.e. the base 1 and the handle 10, 12 can be separated.

In FIG. 27, the movable handle component 12 has then been drawn out ofthe additional handle component 10, where the injection means 15 hasbeen transferred back into a protective position.

In FIG. 28, a connector 64 comprising a supply conduit can then bedocked with the base 1, in order to supply a medicine, for exampleinsulin.

FIG. 29 shows that the link guide 42 has a first portion 42 a of lengtha. This path a serves to pivot the cannula casing 17 b and with it theinsertion means 5 together with the injection means 15 to the right asshown, by operating or advancing the movable handle component 12, suchthat the link block 44 is moved downwards towards the joint element 6,while the insertion means 5 is transferred from the protective positioninto the application position or insertion position. A second portion 42b of the link guide 42 is provided in order to create a clearance overthe second path b, in order to enable unlatching in order to be able todeflect the connecting means 16 b out of the engagement cavity 49.

Correspondingly in FIG. 30, in which the link block 44 has reached theother end of the link guide 42 relative to the representation inaccordance with FIG. 29, the insertion means 5 together with theinjection means 15 is not only in its application position, but thehandle 10, 12 has also already been unlatched from the base 1 and can bedrawn off, where the injection means 15 is drawn out of the insertionmeans 5.

An unlatching mechanism is additionally shown in the embodiment inaccordance with FIG. 31, as shown by the section E-E reproduced in FIG.32. As can be seen, the movable handle component 12 comprises a controlramp which moves against a deflecting ramp 54 once the movable handlecomponent 12 has been inserted into the additional handle component 10,so as to convey the connecting element 16 out of its engagement with theengagement cavity 49 on the base 1. While the movement for pivoting theinsertion means 5 together with the injection means 15 corresponds tothe path 42 a having the length a, the movement for guiding the controlramp 52 against the deflecting ramp 54 corresponds to the portion 42 bof the link guide 42 in accordance with FIG. 29.

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. The embodiments were chosen anddescribed to provide the best illustration of the principles of theinvention and the practical application thereof, and to enable one ofordinary skill in the art to utilize the invention in variousembodiments and with various modifications as are suited to theparticular use contemplated. All such modifications and variations arewithin the scope of the invention as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

1. An insertion head for medical or pharmaceutical applications, saidinsertion head comprising: a) a base comprising a lower side which canbe positioned on organic tissue; b) an insertion means which is movablymounted by the base and can be inserted into the tissue; c) wherein theinsertion means can be moved relative to the base from a protectiveposition in which a free end of the insertion means is short of thelower side of the base, into an insertion position in which the free endprotrudes beyond the lower side; d) and a detachable receptacle which isopen towards the lower side of the base and can be detached from thebase, and which accommodates at least the free end of the insertionmeans in its protective position.
 2. The insertion head according toclaim 1, wherein the base further comprises an additional receptaclewhich is open towards the lower side of the base and accommodates aportion of the insertion means in its insertion position, wherein theinsertion means protrudes through a cavity in the additional receptacle,into the detachable receptacle.
 3. The insertion head according to claim2, wherein in that the detachable receptacle lengthens the additionalreceptacle in the longitudinal direction of the insertion means andaccommodates the additional receptacle.
 4. The insertion head accordingto claim 2, wherein the additional receptacle comprises an outer surfacewhich slopes outwards in a round bulge from its upper side towards thelower side of the base.
 5. The insertion head according to claim 1,wherein the base and a joint element together form a joint, and theinsertion means projects from the joint element, by a longitudinaldirection of the insertion means intersecting or crossing a movementaxis of the joint.
 6. The insertion head according to claim 1, whereinthe insertion means comprises an insertion position, the insertion meansbeing pivotable into the insertion position.
 7. The insertion headaccording to claim 1, further comprising a handle, wherein the handle isdetachably coupled to the base and forms the detachable receptacle. 8.The insertion head according to claim 7, wherein the handle comprises ahandle part which protrudes from an upper side of the base, and thedetachable receptacle projects laterally from the handle part.
 9. Theinsertion head according to claim 7, wherein the handle comprises ahandle component movable relative to the base, and a connection betweenthe base and the handle is released when the movable handle component ismoved.
 10. The insertion head according to claim 7, wherein the handleprotrudes from an upper side of the base.
 11. The insertion headaccording to claim 10, wherein a first connecting element is arranged onthe base, and a second connecting element is arranged on the handle,wherein the connecting elements are in an engagement which creates theconnection, and at least one of the connecting elements can be moved outof the engagement, against an elasticity force.
 12. The insertion headaccording to claim 9, wherein a first connecting element and a secondconnecting element are in an engagement which creates the connection,and the movable handle component contacts one of the connecting elementswhen it is moved, and moves it out of the engagement, against anelasticity force.
 13. The insertion head according to claim 1, whereinthe insertion head is configured as a handle and the handle comprises amovable handle component movable relative to the base, said movablehandle component being coupled to the insertion means such that amovement of the movable handle component relative to the base generatesthe movement of the insertion means.
 14. The insertion head according toclaim 13, wherein the movable handle component is coupled to theinsertion means by means of a transmission.
 15. The insertion headaccording to claim 14, wherein transmission couples the movable handlecomponent to the insertion means by means of a toothed engagement,wherein the toothed engagement comprises a toothed wheel and a toothedrod.
 16. The insertion head according to claim 13, wherein the movablehandle component is coupled to a toothed rod arranged on the movablehandle component, and the insertion means is coupled to a toothed wheel,which is in toothed engagement with the toothed rod.
 17. The insertionhead according to claim 13, wherein the insertion means can be pivotedabout a rotational axis and is non-rotationally coupled to a toothedwheel which is in toothed engagement and can be rotated about therotational axis.
 18. The insertion head according to claim 13, whereinthe movable handle component is configured to be shifted relative to thebase.
 19. The insertion head according to claim 13, wherein the movablehandle component is configured to be linearly guided.
 20. The insertionhead according to claim 13, wherein the movable handle component isconfigured to be moved at least parallel to the lower side of the base.21. The insertion head according to claim 13, further comprising asecuring link associated with the movable handle component, wherein saidmovable handle component accommodates the insertion means in theprotective position, and wherein the insertion means can be latched intosaid securing link in the protective position.
 22. The insertion headaccording to claim 13, wherein the handle further comprises anadditional handle component which is fixed relative to the base whencoupled and forms the detachable receptacle.
 23. The insertion headaccording to claim 13, wherein the handle comprises an additional handlecomponent, and the movable handle component and the additional handlecomponent are configured such that they can be gripped between twofingers of a hand, wherein with each finger pressing against one of thehandle components, the movable handle component can be moved against theadditional handle component.
 24. The insertion head according to claim23, wherein the movable handle component is configured to be shifted farenough into the additional handle component that, once the process fortransferring the insertion means from the protective position into theinsertion position has been completed, a control ramp on the movablehandle component abuts against a deflecting ramp on a connecting elementwhich reversibly connects the base to the handle, and deflects out of anengagement position, such that the handle and the base can be separated.25. The insertion head according to claim 23, wherein the receptacle andthe additional handle component comprise one piece, and wherein thereceptacle is independent from the base.
 26. The insertion headaccording to claim 23, wherein the insertion means is associated with aholding structure which is moved with the insertion means, wherein theholding structure comprises a latching collar which, when the movablehandle component is drawn out of the additional handle component, entersinto a latching engagement with an engaging element on the movablehandle component, in order to prevent the injection means from pivotingout again.
 27. The insertion head according to claim 23, wherein theinsertion means is associated with a holding structure which is movedwith the insertion means, wherein the holding structure comprises asecuring structure which opposes a wall of the movable handle componentwhich extends parallel to the movement direction of the movable handlecomponent, wherein an engaging element on the inner side of this wall isin reversible engagement with the securing structure when the insertionmeans is in its protective position.
 28. The insertion head according toclaim 23, wherein the insertion means is held on the base via arotational axis, wherein a link block is provided which is arrangednon-centrically in relation to the rotational axis, wherein a link guideis provided which co-operates with the link block; and wherein amovement of the movable handle component relative to the base over afirst path of a first portion of the link guide transfers the linkblock, guided by the link guide, from a first position which correspondsto the protective position of the insertion means, into a secondposition which corresponds to the insertion position of the insertionmeans.
 29. The insertion head according to claim 28, wherein aconnecting means is provided which reversibly connects the base to thehandle, wherein in order to detach the handle from the base, the movablehandle component is movable over a second path perpendicular to theextending direction of the insertion means situated in the insertionposition, wherein the link guide comprises a second portioncorresponding to the second path.
 30. The insertion head according toclaim 23, wherein the movable handle component can be shifted far enoughinto the additional handle component that, once the process fortransferring the insertion means from the protective position into theinsertion position has been completed, a control ramp on the movablehandle component abuts against a deflecting ramp on a connecting elementwhich reversibly connects the base to the handle, and deflects out of anengagement position, such that the handle and the base can be separated.31. The insertion head according to claim 23, wherein the insertionmeans is associated with a holding structure which is moved with theinsertion means, wherein the holding structure comprises a latchingcollar which, when the movable handle component is moved relative to theadditional handle component, enters into a latching engagement with anengaging element, in order to prevent the injection means from pivotingout again.
 32. The insertion head according to claim 1, wherein theinsertion means is flexible and is stabilized by an injection meanswhich can be moved together with the insertion means from the protectiveposition into the insertion position.
 33. The insertion head accordingto claim 32, wherein the injection means is coupled to the detachablereceptacle when the insertion means is moved into the insertionposition.
 34. The insertion head according to claim 1, wherein theinjection means and the detachable receptacle are configured to bedetachable from the base and the insertion means.
 35. The insertion headaccording to claim 1, wherein the insertion means is elongated in alongitudinal direction, and the longitudinal direction and the lowerside of the base enclose an acute angle of less than 50° when the freeend of the insertion means protrudes beyond the lower side as it movesinto the insertion position.
 36. The insertion head according to claim1, wherein the base mounts the insertion means such that the insertionmeans is pivotable about a rotational axis, and the insertion meansexhibits a longitudinal axis which intersects the rotational axis orcrosses it at a distance of at most half the length of the insertionmeans.
 37. The insertion head according to claim 1, wherein a securinglink is provided in the receptacle accommodating the insertion means inthe protective position.
 38. The insertion head according to claim 37,wherein the securing link can be moved into a locking position which isassociated with the insertion means and is close to the protectiveposition.
 39. The insertion head according to claim 38, wherein alatching collar is associated with the locking position.
 40. Theinsertion head according to claim 1, wherein the insertion means isassociated with a securing structure which reversibly secures theinsertion means in the protective position.
 41. The insertion headaccording to claim 40, wherein the insertion means is associated with acannula casing which is moved with the insertion means, wherein thecannula casing comprises a securing structure which opposes a wall ofthe movable handle component which extends parallel to the movementdirection of the a second handle component, wherein an engaging elementon the inner side of this wall is in reversible engagement with thesecuring structure when the insertion means is in its protectiveposition.